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Senior Specialist, Site Contracts is responsible for developing, reviewing, and assisting with the negotiation of Site Agreements with Institutions and Investigators and providing oversight and expertise to all site contract activities during all stages of a Clinical Trial. This includes the development of investigator grants, Clinical Trial Agreement templates and applicable plans, negotiation of Clinical Trial Agreements and ancillary agreements, and mitigation of site contracting risks.
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Thiruvananthapuram, IND
, IND
, USA
, USA
, USA
, USA
, GBR
, GBR
Advanced Contract Negotiation Proficient in negotiating complex contract terms with clinical sites and vendors Skilled in resolving contract issues and disputes efficiently
Proficient in negotiating complex contract terms with clinical sites and vendors
Skilled in resolving contract issues and disputes efficiently
Regulatory Compliance Thorough understanding of international and local regulatory requirements for clinical trials (e.g., U.S. Food and Drug Administration [FDA], European Medicines Agency [EMA], International Council for Harmonisation - Good Clinical Practice [ICH-GCP]) Ensures all contracts comply with the latest regulations and guidelines
Thorough understanding of international and local regulatory requirements for clinical trials (e.g., U.S. Food and Drug Administration [FDA], European Medicines Agency [EMA], International Council for Harmonisation - Good Clinical Practice [ICH-GCP])
Ensures all contracts comply with the latest regulations and guidelines
Communication Excellent verbal and written communication skills for effective interaction with internal stakeholders and clinical sites Ability to clearly explain complex contract terms and processes Strong problem-solving skills to address and resolve contract-related issues Ability to think critically and strategically to overcome challenges
Excellent verbal and written communication skills for effective interaction with internal stakeholders and clinical sites
Ability to clearly explain complex contract terms and processes
Strong problem-solving skills to address and resolve contract-related issues
Ability to think critically and strategically to overcome challenges
Collaboration and Teamwork Ability to work effectively with cross-functional teams, including legal, finance, and clinical operations Skilled in fostering a collaborative work environment
Ability to work effectively with cross-functional teams, including legal, finance, and clinical operations
Skilled in fostering a collaborative work environment
Technical Proficiency Proficiency in contract management software and tools High level of accuracy in reviewing and drafting contracts Ability to identify and correct discrepancies or potential issues in contract documentation Understanding of budgeting and financial principles related to clinical trial contracts Ability to negotiate cost-effective terms and manage financial aspects of contracts Basic understanding of legal terminology and principles related to contracts Ability to work closely with legal counsel to ensure all contracts meet legal and regulatory requirements Strong time management skills to meet deadlines and manage the contract lifecycle efficiently Ability to handle high volumes of work and perform under pressure Strong project management skills to oversee multiple site contracts simultaneously Ability to prioritize tasks, manage timelines, and ensure contract deliverables are met Advanced analytical skills to review and interpret contract terms and financial data Ability to identify risks and develop mitigation strategies
Proficiency in contract management software and tools
High level of accuracy in reviewing and drafting contracts
Ability to identify and correct discrepancies or potential issues in contract documentation
Understanding of budgeting and financial principles related to clinical trial contracts
Ability to negotiate cost-effective terms and manage financial aspects of contracts
Basic understanding of legal terminology and principles related to contracts
Ability to work closely with legal counsel to ensure all contracts meet legal and regulatory requirements
Strong time management skills to meet deadlines and manage the contract lifecycle efficiently
Ability to handle high volumes of work and perform under pressure
Strong project management skills to oversee multiple site contracts simultaneously
Ability to prioritize tasks, manage timelines, and ensure contract deliverables are met
Advanced analytical skills to review and interpret contract terms and financial data
Ability to identify risks and develop mitigation strategies
3 to 5 years of experience as a Contract Specialist in the clinical research, pharmaceutical, or Contract Research Organization industry
Bachelor's degree or equivalent in Business Administration, Finance, Science, or a related field
Excellent verbal and written English language skills
Proficiency with Microsoft Word, Excel, and Outlook
Knowledge and understanding of International Council for Harmonisation (ICH) and Good Clinical Practice (GCP) Guidelines, as well as local country legislation in the sphere of clinical trials and local regulatory requirements
Promotion to the next level is not automatic based on years of experience. Personnel are evaluated on proven competency, level of responsibility, and ability to work independently.
At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation. The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):
The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.
We love knowing that someone is going to have a better life because of the work we do.
To view our other roles, check out our careers page at Discover a world of difference at Worldwide ! For more information on Worldwide, visit www.Worldwide.com or connect with us on LinkedIn .
Global contract research organization supporting biopharmaceutical clinical development.
Visit company websiteUSD 71500-142500 yearly / year
Full-time
Senior · 3+ years experience
Remote
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